MAUDE Adverse Event Report: ICU Medical Healthcare Manufacturing S.A. de C.V. CADD Medication Cassette Reservoir; Set, administration, intravascular

Catalog Number	21-7301-24
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During production involving the 50 ml gray cadd cassettes, a 100% visual inspection identified one cassette containing particulate matter.These cassettes were utilized by integradose for the administration of the controlled substance, fentanyl citrate.Upon evaluation, staff reported that one particle appeared fiber-like and fragmented into smaller pieces when agitated, while the remaining particles were described as small, brownish, oblong-shaped particulates.No patients were exposed to the affected cassette, and no patient harm or adverse events were reported.
Additional Manufacturer Narrative
No information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filled as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

• Brand Name: CADD Medication Cassette Reservoir
• Common Device Name: Set, administration, intravascular
• Manufacturer (Section D): ICU Medical Healthcare Manufacturing S.A. de C.V.; ave calidad no. 4, parque; industrial int'l tijuana; tijuana NA 22425 ; MX 22425
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; +1(224)706-2300
• MDR Report Key: 50805923
• Report Number: 9617604-2026-00796
• Device Sequence Number: 18794242
• Product Code: FPA
• UDI-Device Identifier: 10610586027215
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K040636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/17/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 21-7301-24
• Device Lot Number: 6176716
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2026
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/13/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown